Zimmer Biomet Recalls Orthopedic Plates Due to Labeling Mismatch
Zimmer Biomet is recalling 52 orthopedic plates because the package labels did not match the products inside.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the package contents did not match the label, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Zimmer Biomet, Inc. is recalling 52 units of Zimmer Universal Locking System 3.5mm Locking Reconstruction Plates and Dual Compression Plates. The recall was initiated because the product on the package label did not match the product inside the package. Specifically, the label indicated part number 00-4936-011-13 and lot number 62968956, while the product inside was part number 00-4936-008-07 and lot number 62968974.
The affected devices are indicated for temporary internal fixation and stabilization of osteotomies and fractures. The recall covers units distributed worldwide, including the United States (specifically MN, NY, MS, AL, OH, KY, ME, and NM) and several international countries such as Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.
Healthcare providers and facilities that have received these specific part and lot numbers should stop using the devices and contact Zimmer Biomet for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and…
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part 00-4936-011-13
- Lot 62968956 3.5MM ULS RECON PLATE 11H Part 00-4936-008-07
- Lot 62968974 3.5MM ULS DUAL COMP PLT 8
Distribution
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